Job Description
About the Role
In this role, you will ensure the highest standards of product quality and analytical accuracy across all stages of production. You will oversee quality control processes, review analytical data, and authorize product release to guarantee compliance with regulatory requirements and internal specifications. Additionally, you will perform and validate analytical testing methods, collaborate with cross-functional teams to resolve quality issues, and maintain precise documentation to support operational excellence. This position requires strong leadership, analytical expertise, and meticulous attention to detail to uphold the integrity and safety of all products.
Quality-Related Duties
● Review 3rd party analytical lab reports and in-house lab results, comparing them to finished product specification sheets to authorize product release.
● Reject any component or product if specifications are not met.
● Review and approve components, labels, packaging materials, and ingredients for conformance to specifications.
● Authorize treatments, in-progress treatments, and rework/reprocessing of materials to correct specification deviations, including alk blend and leftover batch material processing.
● Release products from quarantine based on test results.
● Ensure all analytical processes meet cGMP CFR 110 and 111 requirements, as well as state and federal regulations.
● Verify quality and safety of raw materials, in-progress samples, and finished products through in-house potency and residual solvent testing using HPLC and GC-MS.
● Perform shelf-life validations via accelerated studies or retention sample analysis.
Analytical-Related Duties
● Perform analytical testing using HPLC and GC-MS to assess composition and purity of materials and products.
● Conduct routine and non-routine analyses on raw materials, intermediates, and final products.
● Develop, validate, and continuously optimize analytical methods to enhance accuracy and efficiency.
● Collaborate with cross-functional teams to address quality control issues and implement corrective actions.
● Maintain accurate records of procedures, results, and deviations, and prepare analytical reports for regulatory compliance.
● Ensure proper maintenance, calibration, and prompt troubleshooting of HPLC and GC-MS equipment to minimize downtime.
Requirements
Qualifications / Educational Requirements
● Bachelor’s degree required.
● Valid driver’s license required.
Skills / Experience Requirements
● Minimum five (5) years of analytical chemistry experience; GMP and good documentation experience preferred.
● Strong leadership and communication skills.
● Detail-oriented with excellent problem-solving abilities.
● Ability to work independently and collaboratively in a team environment.
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